Suvorexant and Alcohol
Purpose
This research will translate findings from preclinical research and provide the initial clinical evidence that orexin antagonism reduces motivation for alcohol, as well as other alcohol-associated maladaptive behaviors in people with Alcohol Use Disorder. This study will also provide basic science information about the orexinergic mechanisms underlying the pharmacodynamic effects of alcohol in humans. As such, the outcomes will contribute to our understanding of the clinical neurobiology of Alcohol Use Disorder. Overall, the proposed work seeks to expand the scope of current clinical neuroscience research on alcohol addiction by focusing on orexin, which has strong preclinical evidence supporting its critical role in addiction but remains unstudied in humans.
Condition
- Alcohol Use Disorder
Eligibility
- Eligible Ages
- Between 21 Years and 55 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
Criteria
Inclusion/Exclusion Criteria:
1. Able to speak and read English.
2. Not seeking treatment at the time of the study.
3. Between the ages of 21 and 55 years.
4. Engaging in at least one binge drinking episode, per the NIAAA definition, in the
last 30 days.
5. Fulfillment of moderate or severe DSM-5 diagnostic criteria for AUD based on
computerized SCID results reviewed by a psychiatrist or psychologist.
6. ECG, read by cardiologist, within normal limits.
7. Body mass index of 19 - 35.
8. Birthing individuals using an effective form of birth control and not pregnant or
breast feeding.
9. Judged by the medical staff to be psychiatrically and physically healthy (i.e., no
current severe SUD or psychiatric diagnoses other than AUD or Tobacco Use DisorderĶ¾
no current physical diagnoses that would interfere with study participation
according to study physician judgment).
10. Not currently physiologically dependent on any substances.
11. Able to abstain from alcohol during admission (i.e., not physically dependent on
alcohol and scores less than 8 on Clinical Institute Withdrawal Assessment for
Alcohol [CIWA-Ar] at screening).
12. Not currently taking any prescribed medications for a chronic condition (other than
birth control).
13. No indication of sleep apnea on the STOP-Bang questionnaire (score of 5 or greater).
14. No contraindications/allergies to suvorexant.
Study Design
- Phase
- Early Phase 1
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover Assignment
- Primary Purpose
- Basic Science
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Placebo Comparator Placebo |
Subjects will be treated daily with an oral placebo. |
|
Experimental Suvorexant Dose 1 |
Subjects will be treated daily with oral suvorexant (10 mg). |
|
Experimental Suvorexant Dose 2 |
Subjects will be treated daily with oral suvorexant (20 mg). |
|
Recruiting Locations
UK Center for Clinical and Translational Science and nearby locations
Lexington, Kentucky 40507
More Details
- NCT ID
- NCT06326684
- Status
- Recruiting
- Sponsor
- University of Kentucky